NZ199151A - Cosmetic cleanser composition - Google Patents

Description

New Zealand Paient Spedficaiion for Paient Number 1 99151 199151 Priority DrM'.. .3 ;P.S\ Ft!od: & 13 Cam^zto C *." p p — ,-v^ : J.Q'i, .. fiS NOV-fogA- &L& lV$ r ••;•; !3 NEW ZEALAND PATENTS ACT, 1953 No.: Date: COMPLETE SPECIFICATION COSMETIC CLEANSER FORMULATION dkWe, ELI LILLY AND COMPANY a corporation of the State of Indiana, United States of America, having a principal place of business at 307 East McCarty Street, City of Indianapolis, State of Indiana, United States of America hereby declare the invention for whichxbc/ we pray that a patent may be granted to njg^us, and the method by which it is to be performed, to be particularly described in and by the following statement:- - 1 ~ (followed by page la) / ?<? /<1 X- 5738 -In. - This invention relates to a novel cosmetic cleanser formulation, which is non-irritating and non-stinging. The cleanser formulation can be used in conjunction with other cosmetic formulations. When the instant cleanser is used with the other below mentioned products in a four-component regime, the method results in decreasing the sensitivity of sensitive skin. Thus, the instant cleanser, as part of a regime, will make sensitive skin less sensitive. Sensitive skin is defined as skin which is fragile, delicate, and reacts by stinging or becoming irritated to certain cosmetics and fragrances. Also sensitive skin is affected more adversely than normal skin by such things as weather changes and sun.

The cleanser formulation is one of a four-component regime, which is used to treat sensitive skin. The other three components are: a toner, a moisturizer, and a cream. Each of the other three 20 components is a separate invention; the toner is claimed in New Zealand Patent Specification No. 199152, also filed of even date herewith; the moisturizer is claimed in New Zealand Patent Specification No. 199153, filed of even date herewith; and the cream is claimed 25 in New Zealand Patent Specification No. 199154, filed of even date herewith. In addition, a cream pack formulation is claimed in New Zealand Patent Specification No. 199155, filed of even date herewith. <=> 1991 5 The cleanser formulation contains oil phase ingredients which contribute to the desensitizing process. These ingredients are listed under Phase 1, while Phase 2 contains other ingredients used in 5 completing the cleanser formulation.

Phase 1 of the cleanser formulation consists of: magnesium aluminum silicate; polyoxyethylene (10) sterol; polyoxyethylene (3) alkyl ether esters of aliphatic c^2-14 ^attY acids; aliphatic C2.6-22 10 alcohols; non-ionic, self-emulsifying glycerylmonoester; polyisoprene with a MW range of 365-480; and/or poly-dimethylcyclosiloxane. Any, a combination, or all of the listed cleanser ingredients can be used to comprise Phase 1 as long as Phase 1 results in about 40% to 15 about 81.5% of the final total cleanser formulation.

Phase 2 of the cleanser formulation consists of mainly aqueous ingredients used to complete the formulation. Such ingredients include: glyoxyldiureide, polyhydric <^2-6 alcohol with a MW range of 285-630; sodium carboxy-20 methyl cellulose; polyphenylmethylsiloxane; liquid sorbitan fatty acid esters with HLB ranges of 1.5-4.0; and the like. In addition, preservatives, colors, and essences can be used to complete a cleanser formulation. A sufficient quantity of deionized water is also added. 25 The cleanser formulation consists of, in percent by weight: 1 991 Cleanser Phase 1 Ingredient Percent magnesium aluminum silicate 0.5-1.50 polyoxyethylene (10) sterol 0.5-4.0 polyoxyethylene (3) alkyl ether 8.0-20.0 esters of aliphatic c^2-14 fattY acids aliphatic c^g_22 fattY alcohols 3.0-6.0 non-ionic, self-emulsifying glyceryl- 1.0-5.0 monoester polyisoprene with a MW range of 365-480 5.0-30.0 polydimethylcyclosiloxane 0.0-15.0 The ingredients of Phase 1 must comprise about 4 0% to about 81.5% of the formulation.

Phase 2 Ingredient glyoxyldiureide polyhydric C_ alcohol with a MW range of 285-630 sodium carboxymethyl cellulose polyphenylmethylsiloxane liquid sorbitan fatty acid esters with HLB ranges of 1.5-4.0 preservative color essence deionized water Percent 0.0-0.7 0.0-7.0 0.0-2.0 0.0-15.0 0.0-4.0 q. s. q. s. q. s. q.s. to 100% 1991 5 X-573-8 The cleanser formulation more particularly and preferably, consists of, in percent by weight: Ingredients propylene glycol magnesium aluminum silicate sodium carboxymethyl cellulose glyoxyldiureide polyoxyethylene (10) soya or tall oil sterols polyoxyethylene (3) myristyl ether myristate squalane (2,6,10,15,19,23-hexamethyl-tetracosane) polydimethylcyclosiloxane stearyl alcohol (1-octadecanol) cetyl alcohol (1-hexadecanol) glyceryl monostearate and polyoxyethylene (100) monostearate preservative deionized water Percent 6. 00 1. 00 0.10 0. 50 2.50 .00 12. 00 12.00 1.50 3. 00 2.00 q. s. q.s. to 100% The ingredient polyoxyethylene (10) sterol includes soya or tall oil sterols and the like, with soya sterol being preferred. Polyoxyethylene (3) alkyl ether esters include myristyl ether myristate and the like, while aliphatic C-]_6-22 alcohols include stearyl and cetyl alcohol and the like. Glyceryl monostearate is a non-ionic, self-emulsifying glyceryl-monoester. A polyisoprene with a MW range of about 365-480 can be squalane. A typical polyhyajric C2-6 alcohol with a MW range of 285-630 is propylene glycol, while liquid sorbitan fatty acid esters with HLB ranges of 1.5-4.0 include polyoxyethylene (100) monostearate. 199151 * 5730 -5- Various classes of emollients which can be used when needed are: steroid alcohols; fatty alcohols; polyhydric alcohol esters; fatty alcohol esters; alkyl fatty esters; and silicone oils.

^ One skilled in the cosmetic formulation art will appreciate that various preservatives can be added to the formulation in sufficient quantities. These preservatives include the esters of p-hydroxybenzoic acid, such as methyl p-hydroxybenzoate, and propyl p-hydroxybenzoate; cis-1-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane chloride; ethylenediamine-tetraacetic acid (EDTA) and salts of EDTA; imidazolidinyl urea; sodium N-lauryl-fU-iminodipropionate; and others or any combination thereof. The total amount of pre- . . servative used can vary, but usually it is from about 0.3 to about 1.0 percent.

In addition, color and essence can be included in the formulation as desired. Color additives would include both natural and artificial dyes, such as 199151 ■36- 5 739 carotenoid derivatives, D+C, F,D+C colors, iron oxides, and others, while essences can include any non-irritating natural and artificial oils, perfumes, and other known essences. non-stinging, according to standard cosmetic testing procedures. The first procedure utilized was the Lanman-Maibach Cumulative Irritation Test, which is a 21-day patch irritation procedure as described by Dr. 10 B. M. Lanman at the Joint Conference on Cosmetic Sciences, April 21-23, 1968 in Washington, D.C. as further modified in Phillips, L., Steinberg M., Maibach, H., and Akers, W., Toxicology and Applied Pharmacology 21, 369-382 (1972). Twenty-one consecutive applications 15 of the cleanser formulation contacted the skin for 23 hours using a semi-occluded patch. Scoring for cumulative irritation and reapplication was done every 24 hours or until excessive irritation was noted at any scoring session. The following classification system 20 was used to standardize the interpretation of Base^/*10 irritation scores: The formulation is both non-irritating and Score Indication 581-630 200-449 450-580 50-199 0-49 mild-no irritation probably mild possibly mild cummulative irritant primary irritant The score for the instant cleanser formulation was 0 Clearly, the cleanser formulation is non-irritating on a normal population by this test. 1991 511 The non-stinging properties of the formulation were established by the Lactic Acid Sting Test as described in P. J. Frosch and A. M. Kligman: "A Method for Appraising the Stinging Capacity of Topically 5 Applied Substances" Journal of the Society of Cosmetic Chemists 28, 197-209, May 1977. Briefly, this test is performed only on subjects who have been pre-selected and show a susceptibility to stinging. The screening test is performed at room temperature while the actual 10 sting test for the cleanser formulation is performed in an environmental chamber having a 30%relative humidity, at a temperature of 54°C. The subjects are brought to a state of profuse sweating which usually occurs after 15 minutes. For the screening test, a 15 liberal amount of 10% aqueous lactic acid is rubbed onto one side of the face and water is rubbed onto the other side of the face, particularly to the nasolabial fold. For the actual test the cleanser formulation is rubbed onto one side of the face. The subject is 20 interrogated for stinging sensations at several timed intervals after application. The following grading system is used: Score Stinging 0 ' none 1 slight 2 moderate 3 severe Scores are the mean of sensations recorded at 2.5, 30 5 and 8 minutes on ten subjects. The Mean Delayed Sting Score for the instant cleanser formulation is 199151 -X~5730 -8- 0.37. Thus, the results of this test show that the cleanser formulation possesses no stinging potential.

In general, the individual ingredients used in the formulation should be of a quality or purity 5 (such as U.S.P. or N.F.) suitable for cosmetic use.

The usual means of preparing this formulation is well understood by one skilled in the art. The oil phase ingredients are prepared and then separately prepared are the water dispersible or soluble phase 10 ingredients. After the two phases are emulsified, additional ingredients such as color and essence are included. Typical preparations can be found in Sagarin E., Cosmetics Science & Technology, Interscience Publishers, NY 1957, 3d print 1966. 15 The formulation is prepared by mixing the ingredients according to conventional methods and the preparation of this formulation is described in the following example. The example is illustrative of the formulation, but is not to be construed as limiting the 20 invention.

Example Cleanser Formulation: Phase Ingredient Percent by' weight A deionized water 43.03 Allantoin (Sutton and Schuylkill, glyoxyldiureide) 0.50 methylparaben (methyl p-hydroxybenzoate) 0.20 ethylenediaminetetraacetic acid 0.02 imidazolidinyl urea 0.30 * a 199151 X 5730 Phase Ingredient Percent by weight B propylene glycol 6.00 Veegum K (R.T. Vanderbilt, magnesium ' aluminum silicate) 1.00 sodium CMC-7MF (Hercules, sodium carboxymethyl cellulose) 0.10 C stearyl alcohol (1-octadecanol) 1.50 cetyl alcohol (1-hexadecanol) 3.00 Arlacel 165 (I.C.I. United States, glyceryl monostearate and polyoxyethylene (100) monostearate 2.00 POE (10) soya sterol (polyoxyethylene (10) soya sterols) 2.50 Standamul 1414E (Henkel, polyoxyethylene (3) myristyl ether myristate) 15.00 Robane (Robeco, squalane) 12.00 Silicone Fluid...34.4 (Dow Corning, polydimethylcyclosiloxane) 12.00 propylparaben (propyl p-hydroxybenzoate) 0.10 butylparaben (butyl p-hydroxy- benzoate) 0.10 D deionized water 0.50 Dowicil 200 (Dow Chemical, cis-1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride) 0.15 Procedure Phase A is prepared in a jacketed tank equipped with a propeller stirrer and side-sweep mixer, heated to about 75-80°C, and mixed until all the powders are dissolved. The gums of Phase B are added to the propylene glycol and mixed until a uniform slurry is obtained. 199151 X-5 7 3-8 -10- Phase B is slowly added to Phase A while mixing rigorously, but without aerating. The temperature is maintained at about 7 5-80°C and Phase AB is mixed until all the gums are dispersed.

The ingredients of Phase C are heated to about 75-85°C and mixed until all the waxes are melted and all the powders dissolved.

Phase C is added to Phase AB while both are at about 75-80°C. Phase ABC is mixed with side-sweep and propeller stirrer for about 15 minutes at about 75-80°C, avoiding aeration. Mixing is continued and Phase ABC is cooled to about 50-55°C. Then Phase D is added, and the product is cooled to about room temperature while mixing.

\ X-5738 -11-

Claims (4)

WHAT WE CLAIM IS:

1. A cosmetic cleanser formulation which comprises, in percent by weight: Ingredient Percent magnesium aluminum silicate 0.5-1.50 polyoxyethylene (10) sterol 0.5-4.0 polyoxyethylene (3) alkyl ether 8.0-20.0 esters of aliphatic c^2-14 ^attY acids aliphatic C2.6-22 ^attY alcohols 3.0-6.0 non-ionic, self-emulsifying glyceryl- 1.0-5.0 \ 10 15 20 25 30 monoester polyisoprene with a MW range of 365-480 5.0-30.0 polydimethylcyclosiloxane 0.0-15.0 which above total of ingredients results in 40% to 81.5% of the final total cleanser formulation, and the remaining ingredients comprise Fhase 2 as herein defined which is an aqueous phase.

2. A cosmetic cleanser formulation of Claim 1 which comprises, in percent by weight, ingredients in Riase 2 as herein defined which is an aqueous phase: Ingredient Percent glyoxyldiureide 0.0-0,7 polyhydric C- alcohol with a MW range 0.0-7.0 of 285-630 sodium carboxymethyl cellulose 0.0-2.0 polyphenylmethylsiloxane 0.0-15.0 liquid sorbitan fatty acid esters 0.0-4.0 with HLB ranges of 1.5-4.0 preservative q.s. color q.s. essence q.s. deionizea water q.s. to 100% 199151 -12-

3. A cosmetic cleanser formulation of claim 1 which comprises, in percent by weight: Ingredients Percent propylene glycol 6.00 magnesium aluminum silicate 1.00 sodium carboxymethyl cellulose 0.10 glyoxyldiureide 0.50 polyoxyethylene (10) soya or tall oil sterols 2.50 10 polyoxyethylene (3) myristyl ether myristate 15.00 squalane (2,6,10,15,19,23-hexamethyl- tetracosane) 12.00 polydimethylcyclosiloxane 12.00 stearyl alcohol (1-octadecanol) 1.50 cetyl alcohol (1-hexadecanol) 3.00 glyceryl monostearate and polyoxyethylene (100) monostearate 2.00 preservative q.s. deionized water q.s. to 100% 20 25

4. A cosmetic cleanser formulation substantially as hereinbefore described with reference to the example. ; DATED THIS 3 ^ DAY OE ^ 19 A. J. PARK & SON PER C.yL Q^Lo^C^1 30 AGGMTS FOR THE APPLICANTS